Research Triangle Park, N.C. October 6, 2009. Novella Clinical Inc. (formerly PharmaLinkFHI) announced today that it has appointed Kimberly Hunsicker, MSN, CRNP, MBA, as Vice President, Project Management, Medical Device & Diagnostics Division (MD&D). Ms. Hunsicker is responsible for the strategic imperatives of the MD&D division and oversees all MD&D clinical programs, ensuring that timelines and deliverables meet or exceed client expectations.
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Prior to joining Novella Clinical, Ms. Hunsicker was Director of Clinical Programs at a J&J Medical Device Company, where she was responsible for developing a Clinical Programs Department for Class II and III devices. From 2000-2009, she held progressive positions within clinical development at J&J, ranging from Clinical Project Manager to Director and held leadership positions for over 3 years within the J&J MD&D Clinical Process Team. Prior to J&J, Kimberly was a Certified Registered Nurse Practitioner at Lehigh Valley Hospital where she was a Women’s Health care provider and directed the execution of Women’s Health IND and IDE clinical trials. She has monitored, managed and directed studies in a wide range of therapeutic areas, including Women’s Health, Urology, Urogynecology, Reproductive Endocrinology and Infertility, Infectious Disease, Wound Care, Plastic Surgery, Biologic & Synthetic Internal Sealants, and Topical Skin Adhesives.
“We are delighted to have Kimberly join the Novella Clinical team. The medical device sector has been a cornerstone for our recent success and Novella has already established a position as a leader in this underserved market. Kimberly’s deep device background coupled with her strong leadership skills further strengthen the Novella Clinical MD&D division and ensures that Novella continues to grow by delivering the experience, quality and customer service that our medical device clients require,” commented Richard Staub, President and Chief Executive Officer.
“Novella Clinical has expanded its Medical Device and Diagnostic capabilities to meet the growing needs of device sponsors facing increased FDA scrutiny to justify product safety and effectiveness. Developers of medical devices have very different and unique requirements as compared to their Biopharmaceutical counterparts and Novella is strengthening our commitment to meeting those unique needs,” added Ms. Hunsicker.
About Novella Clinical
For over a decade, Novella Clinical has been an active partner is supporting the medical device and biopharmaceutical industries with early phase through post-marketing development programs.. Although our clinical experience is all-inclusive, our eClinical roots enable us to offer services that are specific to our clients’ needs, often eliminating the demand to contract with multiple partners. From protocol development through final clinical study report — we integrate deep clinical expertise with industry-leading technologies and a proven approach to support, streamline and expertly resource the entire product development process. Our focus on quality customer service is reflected in our certification by Underwriters Laboratories on meeting global quality standards (ISO 9001:2008). For more information, visit www.novellaclinical.com.
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